Abbott gets USFDA clearance for FreeStyle Libre 2, FreeStyle Libre 3 sensors for integration with automated insulin delivery systems
Abbott Park, Ill.: Abbott has announced that the U.S. Food and Drug Administration (FDA) has cleared its FreeStyle Libre 2 and FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) system sensors for integration with automated insulin delivery (AID) systems. Abbott modified the sensors to enable integration with AID systems.
"Our goal is to make diabetes care as easy as possible," said Jared Watkin, senior vice president for Abbott's diabetes care business. "The FreeStyle Libre portfolio is already the most prescribed CGM in the United States and, with the integration of automated insulin delivery systems, people in the U.S. will soon have an affordable option to pair with insulin pumps. This means less time thinking about diabetes and more time living."
AID systems help people manage daily diabetes care by automatically adjusting and administering the insulin delivered by an insulin pump based on real-time glucose data from their FreeStyle Libre 2 or FreeStyle Libre 3 sensors.
"Abbott is working with leading insulin pump manufacturers to integrate their systems with the FreeStyle Libre 2 and FreeStyle Libre 3 sensors as soon as possible.
The company is partnering with Insulet and Tandem for future integrations in multiple countries, including the U.S.," the company stated.
Outside the U.S., Abbott's FreeStyle Libre 3 sensor is already authorized to work with the mylife Loop solution from Ypsomed and CamDiab in Germany, with additional launches in the UK, Switzerland and the Netherlands planned for the first half of this year.
The modified sensors were also cleared for use by children as young as two years old and for wear time up to 15 days. Current FreeStyle Libre 2 and FreeStyle Libre 3 sensors available today in the U.S. are approved for people four years and older and have a wear time of up to 14 days.
Additionally, the clearance allows for FreeStyle Libre 2 and FreeStyle Libre 3 sensors – both those available today and the modified sensors available in the future – to be used by women with all types of diabetes (Type 1, Type 2 and gestational) who are pregnant.
The modified FreeStyle Libre 2 and FreeStyle Libre 3 sensors will be available in the U.S. later this year. Over time, the modified sensors will replace the current FreeStyle Libre 2 and FreeStyle Libre 3 sensors available today in the U.S.
Read also: Abbott to buy Cardiovascular Systems for USD 890 million
